BCS II waiver approach [Dissolution / BCS / IVIVC]

posted by yuvaneshwari – India, 2019-01-23 07:09 (1913 d 04:45 ago) – Posting: # 19801
Views: 3,207

Dear All,

Drug compound is BCS-II [dosage form is solution filled in capsule], and objective is to formulate with Q1 & Q2 sameness to that of Reference. Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.

In the above scenario, can we consider for BCS based waiver approach ?

Complete thread:

UA Flag
Activity
 Admin contact
22,987 posts in 4,824 threads, 1,661 registered users;
79 visitors (0 registered, 79 guests [including 6 identified bots]).
Forum time: 12:54 CEST (Europe/Vienna)

The only way to comprehend what mathematicians mean by Infinity
is to contemplate the extent of human stupidity.    Voltaire

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5